FDA approves Phase III Actemra COVID-19 trial

Genentech co-conducting with HHS Biomedical Advanced Research and Development Authority (BARDA)

Actemra product image

A late-phase clinical trial in patients with severe case of the 2019 novel coronavirus (COVID-19) would be conducted with Actemra, solely distributed by JW Pharmaceutical in Korea.

 

Roche Group’s Genentech has announced on Mar.

 

23 the U.S.

 

Food and Drug Administration (FDA) has approved Actemra’s (tocilizumab) Phase III clinical trial in adult patients hospitalized with severe case of COVID-19 to test the medication’s treatment effect and safety profile.

 

The news was out three days after the company informed Actemra is in discussion with FDA about a clinical trial to confirm its effect on COVID-19.

 

Genentech is co-conducting the study with Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S.

 

Department of Health and Human Service (HHS) Office of the Assistant Secretary for Preparedness and Response.

 

The primary and secondary endpoints are clinical status of a patient and mortality rate, and necessity of mechanical ventilator and ICU.

 

Prior to the U.S.

 

health authority’s approval, Actemra’s clinical trials in COVID-19 patient have been initiated globally to test effect and safety.

 

But the study distinguishes itself from the previous studies with intricately designed protocol.

 

Genentech stressed, “Actemra has not been indicated to treat patients with COVID-19, and its medical evidence on benefit to COVID-19 treatment has been limited.” Following the U.S.

 

HHS’ order, the company plans to provide 10,000 vials of Actemra to the U.S.

 

government.

 

Alexander Hardy, the CEO of Genentech stated, “We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from COVID-19,” and “the company has decided to conduct this clinical trial in partnership with BARDA and to provide Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS” Actemra is a humanized interleukin-6 (IL-6) receptor antagonist.

 

The subcutaneous injection is widely used to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and cytokine release syndrome (CRS).

 

In 2009, JW Pharmaceutical has signed a deal with Chugai Pharmaceutical under the Roche Group over Actemra for the co-development and exclusive sales in Korean market.

 

The medication was released to the Korean market from 2013, after completing a Phase III study.

 

In July 2014, Actemra SC injection with improved patient adherence was released in the Korean market.